AccessGUDID - DEVICE: Microlife (06970388169498)

GUDID

Device Identifier (DI) Information

Brand Name: Microlife
Version or Model: CUFF-S-WBPA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MICROLIFE USA, INC.

Primary DI Number: 06970388169498
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 176387785 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64510	Arrythmia-detection blood pressure ambulatory recorder	An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for the 24-hour recording of blood pressure and detection of cardiac arrythmias [e.g., atrial fibrillation (AF)]; it may in addition measure the heart rate and mean arterial pressure. The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer or mobile phone with a dedicated software. The device typically incorporates a display and controls, and may include a blood pressure cuff with connection tubing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	System, Measurement, Blood-Pressure, Non-Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b6bd80bd-8d3f-40a6-9abe-20990f9edd8c
Public Version Date: April 18, 2024
Public Version Number: 1
DI Record Publish Date: April 10, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
16970388169495	60	06970388169498		In Commercial Distribution	carton

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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